BEUDAMED
    FDA Enforcement Class III Terminated

    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

    Recall: Z-1419-2018 · Reported April 25, 2018

    Enforcement

    Recall Number
    Z-1419-2018
    Event ID
    79534
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    OraSure Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 25, 2018
    Initiation Date
    December 20, 2017
    Classification Date
    April 18, 2018
    Termination Date
    April 2, 2020
    Address
    1745 Eaton Ave, Bethlehem, PA, 18018-1769, United States

    Description

    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

    Reason

    The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.

    Code Info

    Lot Number: 0006661251, Expiration date: 02/28/2018

    Distribution

    Distributed to 2 consignees in KS.

    Quantity

    10